CLARIFYING PRESSED POWDER- salicylic acid powder

CLARIFYING PRESSED POWDER by

Drug Labeling and Warnings

CLARIFYING PRESSED POWDER by is a Otc medication manufactured, distributed, or labeled by J. A. Cosmetics U.S. INC, Shanghai J. A. Cosmetics Trading CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

SALICYLC ACID 1%

PURPOSE

Purpose:

ACNE TRATMENT

INDICATIONS & USAGE

Uses:

• ​FOR THE TREATMENT OF ACNE
• HELPS PREVENT NEW ACNE BLEMISHES

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product

• KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
• USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

ASK DOCTOR

Stop use and ask a doctor if

• rash occurs.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION

Directions:

• CLEANSETHE SKIN THOROUGHLY BEFORE APPLYING MEDICTION.
  COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY. BEACAUSE EXCESSIVE DRYING OF SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

INACTIVE INGREDIENT

Inactive Ingredient:

TALC, MICA, MAGNESIUM STEARATE, ETHYLHEXYL PALMITATE, PARAFFINUM LIQUIDUM (MINERAL OIL), POLYBUTENE, SODIUM DEHYDROACETATE, METHYLPARABEN, PROPYLPARABEN, FRAGRANCE (PARFUM)

May Contain: TITANUM DIOXIDE (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLARIFYING PRESSED POWDER 
salicylic acid powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
MICA (UNII: V8A1AW0880)
MAGNESIUM STEARATE (UNII: 70097M6I30)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MINERAL OIL (UNII: T5L8T28FGP)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-201-51	1 in 1 BOX
1	NDC: 76354-201-11	30 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/10/2013

Labeler - J. A. Cosmetics U.S. INC (186705047)

Registrant - J. A. Cosmetics U.S. INC (186705047)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai J. A. Cosmetics Trading CO., LTD.		421280183	manufacture(76354-201)